PMA P220020
- Device
- Lava Liquid Embolic System (Lava LES)
- Applicant
- Sirtex Medical, Inc.
- Product code
- QVG
- Decision date
- 2026-07-09
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- implementation of the Automated Viscometer for LAVA LES kinematic viscosity testing
Current openFDA PMA Record#
- Device
- Lava Liquid Embolic System (Lava LES)
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S008
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2026-07-09
- Decision code
- OK30
- Date received
- 2026-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of the Automated Viscometer for LAVA LES kinematic viscosity testing